Clinical Research Nurse Specialist I, BSN, Peds Endo Metabolism
University Hospitals
full-time
Posted on:
Location Type: Hybrid
Location: Cleveland • Ohio • United States
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About the role
- Provide safe and efficient age-specific nursing care to patients/families using the nursing process in combination with clinical research protocol requirements.
- Works in collaboration with the Principal Investigator to coordinate and implement assigned clinical research studies in accordance with Good Clinical Practice (GCP) guidelines.
- Responsible for submission of related documents to the appropriate research review committees and maintenance of regulatory documentation.
- Performs day-to-day activities related to clinical research studies including: recruit and screens participants, obtain informed consent, educate participants regarding study requirements, and complete source documents and case report forms (CRFs).
- Conducts nursing assessments of research participants including appropriate reporting.
- Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies.
- Establish and maintain communications with Investigator, Sponsor and internal constituents.
- Performs other duties as assigned.
Requirements
- (BSN) Bachelor's Degree in Nursing (Required)
- 2+ years of clinical experience in patient care (Required)
- Clinical research experience (Preferred)
- Experience in a team setting (Preferred)
- Experience in diabetic research is preferred
- Pharmaceutical clinical trials experience is preferred
- Ability to prioritize the work of multiple projects. (Required proficiency)
- Knowledge of GCP and FDA guidelines. (Required proficiency)
- Detail-oriented person with the ability to collect, compile, and analyze information. (Required proficiency)
- Ability to understand and communicate research protocol requirements to others. (Required proficiency)
- Able to work independently on multiple tasks and manage time effectively. (Required proficiency)
- Medical terminology. (Required proficiency)
- Effective verbal, written and communication skills. (Required proficiency)
- Computer skills : Excel, Access and Word. (Required proficiency)
- Registered Nurse (RN), Ohio and/or Multi State Compact License (Required Upon Hire)
- Certification in Human Subjects Protection (CITI) Good Clinical Practices, HIPAA, and CITI Training (Required within 30 Days)
- Basic Life Support (BLS) (Required within 30 Days)
- OH Driver's License (Valid) with car insurance coverage. (Required)
- DOT/IATA Training (Required within 30 Days)
Benefits
- Complies with all policies and standards.
- Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchnursing assessmentsinformed consentsource documentscase report formsmedical terminologydata analysisproject prioritizationGCP guidelinesFDA guidelines
Soft Skills
detail-orientedeffective communicationteam collaborationindependent worktime management
Certifications
Registered Nurse (RN)CITI Good Clinical PracticesHIPAACITI TrainingBasic Life Support (BLS)DOT/IATA Training